Anal incontinence disease treatment with controlled wireless energy supply

ABSTRACT

A anal incontinence disease treatment apparatus and method include and use an operable restriction device implanted in a patient and engaging the colon or engaging the rectum to form a restricted fecal passageway in the colon or the rectum. A source of energy external to the patient&#39;s body and a control device for releasing wireless energy from the source of energy from outside the patient&#39;s body are provided. The released wireless energy is used in connection with the operation of the restriction device, to enlarge or contract the restricted fecal passageway.

CROSS REFERENCE TO RELATED APPLICATION

This application is based upon provisional application Ser. No.60/148,345 filed Aug. 12, 1999, the disclosure of which is herebyincorporated by reference herein.

BACKGROUND OF THE INVENTION

The present invention relates to an anal incontinence treatmentapparatus and method. More specifically, the invention relates to ananal incontinence treatment apparatus and method for surgicalapplication in the abdomen of a patient for forming a restricted fecalpassageway in the colon or rectum. The term “patient” includes an animalor a human being.

Anal incontinence is a wide-spread disease. Several kinds of sphincterplastic surgery are used today to remedy anal incontinence. There is aprior manually operated sphincter system in an initial clinical trialphase where a hydraulic sphincter system connected to an elasticreservoir (balloon) placed in the scrotum is developed. A disadvantageof this system is that thick, hard fibrosis is created around thereservoir by pump movements making the system useless sooner or later.

U.S. Pat. No. 5,593,443 discloses a hydraulic anal sphincter under bothreflex and voluntary control. A pressure controlled inflatableartificial sphincter is disclosed in U.S. Pat. No. 4,222,377.

SUMMARY OF THE INVENTION

The object of the present invention is to provide a new convenient analincontinence treatment apparatus, the performance of which may beaffected by the patient at any time alter operation, in particular whenneed arise over the course of a day, so that the patient substantiallyalways is satisfied or comfortable.

Accordingly, there is provided an anal incontinence disease treatmentapparatus, comprising an operable restriction device implanted in apatient and engaging the colon or the rectum to form a restricted fecalpassageway in the colon or rectum, a source of energy external to thepatient's body, and a control device for releasing wireless energy fromthe external source of energy, wherein the released wireless energy isused in connection with the operation of the restriction device.

As a result, the advantage is achieved that the implanted restrictiondevice can be non-invasively adjusted by the control device.Furthermore, the apparatus of the invention provides simple andeffective control of the energy supplied to implanted components of theapparatus which ensures an extended and reliable functionality of theapparatus, possibly for the rest of the patient's natural life, and atlest many years.

The restriction device preferably controls the cross-sectional area ofthe fecal passageway in the colon or rectum, which gives the advantagethat the patient is enabled to adjust the cross-sectional area of thefecal passageway whenever he likes during the day. This advantage shouldnot be underestimated

Preferably the control device also controls the restriction device. Thecontrol device may comprise an internal control unit, preferablyincluding a microprocessor, implanted in the patient for controlling therestriction device. The control device may further comprise an externalcontrol unit outside the patient's body, wherein the internal controlunit is programmable by the external control unit, for example forcontrolling the restriction device over time. Alternatively, theinternal control unit may control the restriction device over time inaccordance with an activity schedule program, which may be adapted tothe patient's needs.

Conveniently, the external control unit may load the internal controlunit with data in accordance with a loading mode only authorized for adoctor. For specialized controls of the restriction device, the externalcontrol unit may control the internal control unit in accordance with adoctor mode only authorized for the doctor. For simple controls of therestriction device, the external control unit may control the internalcontrol unit in accordance with a patient mode permitted for thepatient. Thus, by using the external control unit in, accordance withdifferent modes it is possible to have certain functions of therestriction device controlled by the patient and other more advancedfunctions controlled by the doctor, which enables a flexiblepost-operation treatment of the patient.

Generally, the apparatus further comprises an operation device implantedin the patient for operating the restriction device, wherein the controldevice controls the operation device to operate the restriction device.

The operation device may comprise hydraulic means and at least one valvefor controlling a fluid flow in the hydraulic means. The control devicemay suitably comprise a wireless remote control for controlling thevalve. The restriction device may comprise hydraulic means and theoperation device may comprise a reservoir forming a fluid chamber with avariable volume connected to the hydraulic means. The operation devicemay distribute fluid from the chamber to the hydraulic means byreduction of the volume of the chamber and withdraw fluid from thehydraulic means to the chamber by expansion of the volume of thechamber.

In accordance with a first main aspect of the invention, the wirelessenergy is directly used for operation of the restriction device, i.e.the restriction device is operated as the wireless energy is releasedfrom the external source of energy by the control device. The term“directly” is used to mean, on one hand, that the restriction device ispromptly operated by using the released energy without first storing thelatter, on the other hand, that the released energy may be somewhatdelayed, in the order of seconds, by for instance an energy stabilizerbefore being used for the operation of the restriction device. As aresult, a very simple control of the restriction device is achieved andthere are only a few implanted components of the apparatus. For example,there is no implanted source of energy, such as a battery, nor anyimplanted complicated signal control system. This gives the advantagethat the apparatus will be extremely reliable.

The wireless energy may be used for direct operation of the restrictiondevice in a non-magnetic and/or non-mechanical manner.

Generally, the control device controls and directly or indirectly powersthe operation device with wireless energy released from the source ofenergy and/or powers other implanted energy consuming components of theapparatus.

In a first particular embodiment in accordance with the first mainaspect of the invention, the operation device comprises a motor,preferably an electric motor which may have electrically conductiveparts made of plastics. The motor may include a rotary motor, whereinthe control device is adapted to control the rotary motor to rotate adesired number of revolutions. Alternatively, the motor may include alinear motor, or a hydraulic or pneumatic fluid motor, wherein thecontrol device is adapted to control the fluid flow through the fluidmotor. Motors currently available on the market are getting smaller andsmaller. Furthermore, there is a great variety of control methods andminiaturized control equipment available. For example, a number ofrevolutions of a rotary motor may be analyzed by a Hall-element just afew mm in size.

In a second particular embodiment in accordance with the first mainaspect of the invention, the control device is adapted to shift polarityof the polarized energy to reverse the operation device. The operationdevice may suitably comprise an electric motor and the released energymay comprise electric energy.

In a third particular embodiment in accordance with the first mainaspect of the invention, the restriction device is operable to perform areversible function. Such a reversing function preferably involvesenlarging and restricting the fecal passageway by the restrictiondevice, suitably in a stepless manner. There is a reversing deviceimplanted in the patient for reversing the function performed by therestriction device, in this connection, the control device suitablycontrols the reversing device, which may include a switch, to reversethe function performed by the restriction device. The reversing devicemay comprise hydraulic means including a valve for shifting the flowdirection of a fluid in the hydraulic means. Alternatively, thereversing device may comprise a mechanical reversing device, such as aswitch or a gear box.

Where the reversing device comprises a switch the control devicesuitably controls the operation of the switch by shifting polarity ofreleased energy supplied to the switch. The switch may comprise anelectric switch and the source of energy may supply electric energy forthe operation of the switch. The switch mentioned above may comprise anelectronic switch or, where applicable, a mechanical switch.

In accordance with the third particular embodiment, the operation devicepreferably comprises a motor, wherein the reversing device reverses themotor.

In a fourth particular embodiment in accordance with the first mainaspect of the invention, the restriction device comprises hydraulicmeans, for example including an expansible/contractible cavity forfluid. The operation device preferably comprises a pump for pumping afluid in the hydraulic means, a motor for driving the pump, a valvelessfluid conduit between the pump and the hydraulic means of therestriction device, and a reservoir for fluid, wherein the reservoirforms part of the conduit. All of the hydraulic components involved arepreferably devoid of any non-return valve. This is of great advantage,because with valves involved there is always a risk of malfunction dueto improperly working valves, especially when long time periods passesbetween valve operations. The reservoir may form a fluid chamber with avariable volume, and the pump may distribute fluid from the chamber tothe hydraulic means of the restriction device by reduction of the volumeof the chamber and withdraw fluid from the hydraulic means to thechamber by expansion of the volume of the chamber.

In accordance with a second main aspect of the invention, the apparatuscomprises a switch implanted in the patient for directly or indirectlyswitching the operation of the restriction device and an internal sourceof energy, such as a battery, implanted in the patient for supplyingenergy for the operation of the restriction device, wherein the switchdirectly or indirectly affects the supply of energy from the internalsource of energy. This solution is advantageous for embodiments of theapparatus that have a relatively high energy consumption which cannot bemet by direct supply of wireless energy.

In a first particular embodiment in accordance with the second mainaspect of the invention, the switch switches between an off mode, inwhich the internal source of energy is not in use, and an on mode, inwhich the internal source of energy supplies energy for the operation ofthe restriction device. In this case, the switch is convenientlyoperated by the wireless energy released from the external source ofenergy to switch between the on and off modes. The control device,preferably comprising a wireless remote control, may control theexternal source of energy to release the wireless energy. The advantageof this embodiment is that the lifetime of the implanted source ofenergy, such as a battery, can be significantly prolonged, since theimplanted source of energy does not supply energy when the switch is inits off mode.

In a second particular embodiment in accordance with the second mainaspect of the invention, the control device comprises a wireless remotecontrol for controlling the internal source of energy. In this case, theswitch is operable by the wireless energy from the external source ofenergy to switch between an off mode, in which the internal source ofenergy and remote control are not in use, and a standby mode, in whichthe remote control is permitted to control the internal source of energyto supply energy for the operation of the restriction device.

In a third particular embodiment in accordance with the second mainaspect of the invention, the apparatus further comprises an energytransfer device implanted in the patient for transferring the wirelessenergy into storable energy, wherein the internal source of energy iscapable of storing the storable energy. The internal source of energypreferably comprises an electric accumulator, at least one capacitor orat least one rechargeable battery, or a combination of at least onecapacitor and at least one rechargeable battery. In this case, theswitch switches from an off mode, in which the internal source of energyis not in use, to an on mode, in which the internal source of energysupplies energy for the operation of the restriction device.

The control device, preferably comprising a wireless remote control, maycontrol the switch to switch between the on and off modes.

Alternatively, in this third particular embodiment an energy storagedevice may be implanted in the patient for storing the storable energyinstead of the internal source of energy, wherein the switch is operableby energy from the implanted energy storage device to switch between anoff mode, in which the internal source of energy is not in use, and anon mode, in which the internal source of energy supplies energy for theoperation of the restriction device. In this case, the control device(the wireless remote control) controls the energy storage device tooperate the switch.

The internal source of energy preferably comprises an electric source ofenergy, such as an accumulator or a battery having a life-time of atleast 10 years. However, other kinds of sources are also conceivable,such as a nuclear source of energy or a chemical source of energy.

The above first, second and third and fourth particular embodimentsdescribed in connection with the first main aspect of the invention arealso applicable in accordance with the second main aspect of theinvention, i.e. where the apparatus comprises an implanted switch.

All of the above embodiments may be combined with at least one implantedsensor for sensing at least one physical parameter of the patient,wherein the control device may control the restriction device inresponse to signals from the sensor. For example, the sensor maycomprise a pressure sensor for directly or indirectly sensing thepressure against the restriction device, human tissue or in the fecalpassageway. The expression “indirectly sensing the pressure in the fecalpassageway” should be understood to encompass the cases where the sensorsenses the pressure against the restriction device or human tissue ofthe patient. The pressure sensor may be any suitable known orconventional pressure sensor such as shown in U.S. Pat. No. 5,540,731,4,846,181, 4,738,267, 4571,749, 4,407,296 or 3,939,523; or an NPC-102Medical Angioplasty Sensor. Where the control device comprises aninternal control unit implanted in the patient, the internal controlunit may suitably directly control the restriction device in response tosignals from the sensor. In response to signals from the sensor, forexample pressure, the patient's position or any other important physicalparameter, the internal control unit may send information thereon tooutside the patient's body. The control unit may also automaticallycontrol the restriction device in response to signals from the sensor.The control device may control the restriction device in response tosignals from the pressure sensor.

For example, the control unit may control the restriction device tofurther restrict the fecal passageway in the rectum in response to thesensor sensing that the patient is lying, or enlarge the fecalpassageway in response to the sensor sensing an abnormally high pressureagainst the restriction device.

Where the control device comprises an external control unit outside thepatient's body, the external control unit may, suitably directly,control the restriction device in response to signals by the sensor. Theexternal control unit may store information on the physical parametersensed by the sensor and may be manually operated to control therestriction device based on the stored information. In addition, theremay be at least one implanted sender for sending information on thephysical parameter sensed by the sensor.

An external data communicator may be provided outside the patient's bodyand an internal data communicator may be implanted in the patient forcommunicating with the external communicator. The implanted communicatormay feed data related to the patient, or related to the implantedrestriction device, back to the external communicator. Alternatively orin combination, the external communicator may feed data to the internalcommunicator. The implanted communicator may suitably feed data relatedto at least one physical signal of the patient.

Generally, the restriction device may control the cross-sectional areaof the fecal passageway in the colon or rectum. For example, therestriction device may be operable to open and close the fecalpassageway or may steplessly control the cross-sectional area of thefecal passageway. The restriction device may be non inflatable, i.e.with no hydraulic fluid involved for the adjustments of the restrictiondevice. This eliminates problems with fluid leaking from the restrictiondevice.

The apparatus may comprise an implanted energy transfer device, whereinthe control device releases electric energy and the energy transferdevice transfers the electric energy into kinetic energy for, preferablydirect, operation of the restriction device. Suitably, an implantedstabilizer, such as a capacitor or a rechargeable accumulator, or thelike, may be provided for stabilizing the electric energy released bythe control device.

The control device may release energy for a determined time period or ina determined number of energy pulses.

All of the above embodiments are preferably remote controlled. Thus, thecontrol device advantageously comprises a wireless remote controltransmitting at least one wireless control signal for controlling therestriction device. With such a remote control it will be possible toadapt the function of the apparatus to the patient's need in a dailybasis, which is beneficial with respect to the treatment of the patient.

The wireless remote control may be capable of obtaining information onthe condition of the implanted restriction device and of controlling therestriction device in response to the information. Also, The remotecontrol may be capable of sending information related to the restrictiondevice from inside the patient's body to the outside thereof.

In a particular embodiment of the invention, the wireless remote controlcomprises at least one external signal transmitter or transceiver and atleast one internal signal receiver or transceiver implanted in thepatient. In another particular embodiment of the invention, the wirelessremote control comprises at least one external signal receiver ortransceiver and at least one internal signal transmitter or transceiverimplanted in the patient.

The remote control may transmit a carrier signal for carrying thecontrol signal, wherein the carrier signal is frequency, amplitude orfrequency and amplitude modulated and is digital, analog or digital andanalog. Also the control signal used with the carrier signal may befrequency, amplitude or frequency and amplitude modulated.

The control signal may comprise a wave signal, for example, a sound wavesignal, such as an ultrasound wave signal, an electromagnetic wavesignal, such as an infrared light signal, a visible light signal, anultra violet light signal, a laser signal, a micro wave signal, a radiowave signal, an x-ray radiation signal, or a gamma radiation signal.Where applicable, two or more of the above signals may be combined.

The control signal may be digital or analog, and may comprise anelectric or magnetic field. Suitably, the wireless remote control maytransmit an electromagnetic carrier wave signal for carrying the digitalor analog control signal. For example, use of an analog carrier wavesignal carrying a digital control signal would give safe communication.The control signal may be transmitted in pulses by the wireless remotecontrol.

According to yet another aspect of the present invention there isprovided a method of treating a human or animal having anal incontinencedisease, comprising: (a) Surgically implanting in the human or animal anoperable restriction device engaging the human's or animal's colon orrectum to form a restricted fecal passageway in the colon or rectum. (b)Providing a source of energy external to the patient's body. (c)Controlling the external source of energy from outside the patient'sbody to release wireless energy. And (d) using the released wirelessenergy in connection with the operation of the restriction device.

The method may further comprise (e) implanting in the human or animal anoperation device which can adjust the restricted fecal passageway inresponse to supplied energy, and (f) using the released wireless energyto activate the implanted operation device so as (g) to enlarge therestricted fecal passageway to allow feaces to readily pass therethroughbut normally restrict the fecal passageway.

In accordance with an alternative method, there is provided a method oftreating a human or animal having anal incontinence disease, comprisingthe steps of placing at least two laparascopical trocars in the human'sor animal's body, inserting a dissecting tool through the tracers anddissecting an area of the colon or rectum, placing an operablerestriction device in the dissected area, so that the restriction deviceengages the colon or engages the rectum to form a restricted fecalpassageway in the colon or rectum, providing a source of enemy outsidethe human's or animal's body, controlling the external source of energyfrom outside the patient's body to release wireless energy, and usingthe released wireless energy in connection with the operation of therestriction device.

In accordance with another alternative method, there is provided amethod of treating a human or animal having anal incontinence disease,comprising the steps of placing at least two laparascopical trocars inthe human's or animal's body, inserting a dissecting tool through thetrocars and dissecting an area of the colon or rectum, implanting anoperable restriction device in the dissected area, so that therestriction device engages the colon or engages the rectum to form arestricted fecal passageway in the colon or rectum, implanting an energytransfer device, providing an external source of energy, controlling theexternal source of energy to release wireless energy, and transferringthe wireless energy by the energy transfer device into energy differentthan the wireless energy for use in connection with the operation of therestriction device. This method may further comprise implanting astabilizer in the human or animal for stabilizing the energy transferredby the energy transfer device.

It is the primary object of the present invention to provide a simpleyet effective method and apparatus for treating chronic analincontinence disease in humans or animals. This and other objects of theinvention will become clear from an inspection of the detaileddescription of the invention and from the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 to 5 are schematic block diagrams illustrating five embodiments,respectively, of the invention, in which wireless energy released froman external source of energy is used for direct operation of arestriction device engaging the colon or rectum of a patient;

FIGS. 6 to 10 are schematic block diagrams illustrating fiveembodiments, respectively, of the invention, in which a switch isimplanted in the patient for directly or indirectly switching theoperation or the restriction device;

FIG. 11 is a schematic block diagram illustrating conceivablecombinations of implanted components for achieving various communicationoptions;

FIG. 12 illustrates the apparatus in accordance with the inventionimplanted in a patient;

FIG. 13 is a block diagram illustrating remote control components of anembodiment of the invention; and

FIG. 14 is a schematic view of exemplary circuitry used for thecomponents of the block diagram of FIG. 13.

Referring to the drawing figures, like reference numerals designateidentical or corresponding elements throughout the several figures.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1 schematically shows an embodiment of the anal incontinencedisease apparatus of the invention having some parts implanted in apatient and other parts located outside the patient's body. Thus, inFIG. 1 all parts placed to the right of the patient's skin 2 areimplanted and all parts placed to the left of the skin 2 are locatedoutside the patient's body.

The apparatus of FIG. 1 comprises an implanted operable restrictiondevice 4, which engages the patient's colon (or alternatively engagesthe rectum) to form a restricted fecal passageway in the colon orrectum. The restriction device 4 is capable of performing a reversiblefunction, i.e. to enlarge and reduce the cross-sectional area of thefecal passageway, whereby the restriction device works as an artificialsphincter. An implanted control unit 6 controls the restriction device 4via a control line 8 to form an adequate size of the cross-sectionalarea of the restricted fecal passageway. An external control unit 10includes an external source of energy and a wireless remote controltransmitting a control signal generated by the external source ofenergy. The control signal is received by a signal receiver incorporatedin the implanted control unit 6, whereby the control unit 6 controls theimplanted restriction device 4 in response to the control signal. Theimplanted control unit 6 also uses energy from the control signal fordirectly operating the restriction device 4 via a power supply line 12,as the control signal is transmitted.

FIG. 2 shows an embodiment of the invention identical to that of FIG. 1,except that a reversing device in the form of a switch 14 also isimplanted in the patient for reversing the restriction device 4. Thecontrol unit 6 uses the switch 14 to reverse the function performed bythe restriction device 4, i.e. enlarging and restricting the fecalpassageway. More precisely, the external control unit 10 releases energycarried by a wireless signal and the implanted control unit 6 transfersthe wireless energy into a current for operating the switch 14. When thecontrol unit 6 shifts the polarity of the current the switch 14 reversesthe function performed by the restriction device 4.

FIG. 3 shows an embodiment of the invention identical to that of FIG. 1,except that an operation device in the form of a motor 16 also isimplanted in the patient. The implanted control unit 6 powers the motor16 with wireless energy released from the external source of energy ofthe external control unit 10. The implanted control unit 6 controls theoperation of the motor 16 in response to a control signal from theremote control of the external control unit 10.

FIG. 4 shows an embodiment of the invention identical to that of FIG. 1,except that an assembly 16 including a motor/pump unit 18 and a fluidreservoir 20 also is implanted in the patient. In this case therestriction device 4 is hydraulically operated, i.e. hydraulic fluid ispumped by the motor/pump unit 18 from the reservoir 20 through a conduit22 to the restriction device 4 to reduce the cross-sectional area of thefecal passageway, and hydraulic fluid is pumped by the motor/Pump unit13 back from the restriction dc-vice 4 to the reservoir 20 to enlargethe cross-sectional area. The external control unit 10 releases energycarried by a wireless signal and the implanted control unit 6 transfersthe wireless energy into a current, for example a polarized current, forpowering the motor/pump unit 18 via an electric power supply line 24.The implanted control unit 6 controls the motor/pump unit 16 and therestriction device 4 via control lines 26 and 26.

FIG. 5 shows an embodiment of the invention comprising the restrictiondevice 4, hydraulically operated, and the implanted control unit 6, andfurther comprising a hydraulic fluid reservoir 30, a motor/pump unit 32and a reversing device in the form of a hydraulic valve shifting device34, all of which are implanted in the patient. The motor of themotor/pump unit 32 is an electric motor.

In response to a control signal from the wireless remote control of theexternal control unit 10 the implanted control unit 6 powers themotor/pump unit 32 with energy from the control signal, whereby themotor/pump unit 32 distributes hydraulic fluid between the reservoir 30and the restriction device 4. The control unit 6 controls the shiftingdevice 34 to shift the hydraulic fluid flow direction between onedirection in which the fluid is pumped by the motor/pump unit 32 fromthe reservoir 30 to the restriction device 4 to reduce thecross-sectional area of the fecal passageway, and another oppositedirection in which the fluid is pumped by the motor/pump unit 32 backfrom the restriction device 4 to the reservoir 30 to enlarge thecross-sectional area.

FIG. 6 shows an embodiment of the invention comprising the restrictiondevice 4, the external control unit 10, an implanted source of energy 36and an implanted switch 38. The switch 38 is operated by wireless energyreleased from the external source of energy of the external control unit6 to switch between an off mode, in which the implanted source of energy36 is not in use, and an on mode, in which the implanted source ofenergy 36 supplies energy for the operation of the restriction device 4.

FIG. 7 shows an embodiment of the invention identical to that of FIG. 6,except that also the control unit 6 is implanted, in order to receive acontrol signal from the wireless remote control of the external controlunit 10. The switch 38 is operated by the wireless energy from theexternal source of energy 10 to switch between an off mode, in which theimplanted source of energy 36 and the wireless remote control of theexternal control unit 10 are not in use, i.e. the control unit 6 is notcapable of receiving the control signal, and a standby mode, in whichthe wireless remote control is permitted to control the internal sourceof energy 36, via the implanted control unit 6, to supply energy for theoperation of the restriction device 4.

FIG. 8 shows an embodiment of the invention identical to that of FIG. 7,except that an energy transfer device for transferring the wirelessenergy into storable energy is incorporated in the implanted controlunit 6 and that the implanted source of energy 36 is of a type that iscapable of storing the storable energy. In this case, in response to acontrol signal from the external control unit 10, the implanted controlunit 6 controls the switch 38 to switch from an off mode, in which theimplanted source of energy 36 is not in use, to an on mode, in which thesource of energy 36 supplies energy for the operation of the restrictiondevice 4.

FIG. 9 shows an embodiment of the invention identical to that of FIG. 8,except that an energy storage device 40 also is implanted in the patientfor storing the storable energy transferred from the wireless energy bythe transfer device of the control unit 6. In this case, the implantedcontrol unit 6 controls the energy storage device 40 to operate theswitch 38 to switch between an off mode, in which the implanted sourceof energy 36 is not in use, and an on mode, in which the implantedsource of energy 36 supplies energy for the operation of the restrictiondevice 4.

FIG. 10 shows an embodiment of the invention identical to that of FIG.8, except that a motor 42 and a mechanical reversing device in the formof a gear box 44 also are implanted in the patient. The implantedcontrol unit 6 controls the gear box 44 to reverse the functionperformed by the restriction device 4 (mechanically operated), i.e.enlarging and restricting the fecal passageway.

FIG. 11 schematically shows conceivable combinations of implantedcomponents of the apparatus for achieving various communication options.Basically, there are the implanted restriction device 4, the implantedcontrol unit 6 and the external control unit 10 including the externalsource of energy and the wireless remote control. As already describedabove the remote control transmits a control signal generated by theexternal source of energy, and the control signal is received by asignal receiver incorporated in the implanted control unit 6, wherebythe control unit 6 controls the implanted restriction device 4 inresponse to the control signal.

A sensor 46 may be implanted in the patient for sensing a physicalparameter of the patient, such as the pressure in the fecal passageway.The control unit 6, or alternatively the external control unit 10, maycontrol the restriction device 4 in response to signals from the sensor46. A transceiver may be combined with the sensor 46 for sendinginformation on the sensed physical parameter to the external controlunit 10. The wireless remote control of the external control unit 10 maycomprise a signal transmitter or transceiver and the implanted controlunit 6 may comprise a signal receiver or transceiver. Alternatively, thewireless remote control of the external control unit 10 may comprise asignal receiver or transceiver and the implanted control unit 6 maycomprise a signal transmitter or transceiver. The above transceivers,transmitters and receivers may be used for sending information or datarelated to the restriction device 4 from inside the patient's body tothe outside thereof.

Those skilled in the art will realize that the above various embodimentsaccording to FIGS. 1-11 could be combined in many different ways.

FIG. 12 illustrates how any of the above-described embodiments of theanal incontinence disease treatment apparatus of the invention may beimplanted in a patient. Thus, the apparatus comprises a restrictiondevice 48 implanted in the patient and engaging the colon or rectum 50,and an operation device 52 for operating the restriction device 48. Acontrol device in the form of a wireless remote control comprises animplanted control unit 54, which includes a signal receiver, forcontrolling the operation device 52, and an external control unit 56including a signal transmitter for transmitting a control signal to thesignal receiver of the implanted control unit 54. The implanted controlunit 54 is capable of transferring signal energy from the control signalinto electric energy for powering the operation device 52 and forenergizing electric energy consuming implanted components of theapparatus.

FIG. 13 shows the basic parts of a wireless remote control of theapparatus of the invention including an electric motor 128 for operatinga restriction device, for example of the type illustrated in FIG. 12. Inthis case, the wireless remote control is based on the transmission ofelectromagnetic wave signals, often of high frequencies in the order of100 kHz-1 GHz, through the skin 130 of the patient. In FIG. 11, allparts placed to the loft of the skin 130 are located outside thepatient's body and all parts placed to the right of the skin 130 areimplanted. Any suitable remote control system may be used.

An external signal transmitting antenna 132 is to be positioned close toa signal receiving antenna 134 implanted close to the skin 130. As analternative, the receiving antenna 134 may be placed for example insidethe abdomen of the patient. The receiving antenna 134 comprises a coil,approximately 1-100 mm, preferably 25 mm in diameter, wound with a verythin wire and tuned with a capacitor to a specific high frequency. Asmall coil is chosen if it is to be implanted under the skin of thepatient and a large coil is chosen if it is to be implanted in theabdomen of the patient. The transmitting antenna 132 comprises a coilhaving about the same size as the coil of the receiving antenna 134 butwound with a thick wire that can handle the larger currents that isnecessary. The coil of the transmitting antenna 132 is tuned to the samespecific high frequency as the coil of the receiving antenna 134.

An external control unit 136 comprises a microprocessor, a highfrequency electromagnetic wave signal generator and a power amplifier.The microprocessor of the control unit 136 is adapted to switch thegenerator on/off and to modulate signals generated by the generator tosend digital information via the power amplifier and the antennas132,134 to an implanted control unit 138. To avoid that accidentalrandom high frequency fields trigger control commands, digital signalcodes are used. A conventional keypad placed on the external controlunit 136 is connected to the microprocessor thereof. The keypad is usedto order the microprocessor to send digital signals to either contractor enlarge the restriction device. The microprocessor starts a commandby applying a high frequency signal on the antenna 132. After a shorttime, when the signal has energized the implanted parts of the controlsystem, commands are sent to contract or enlarge the restriction devicein predefined steps. The commands are sent as digital packets in theform illustrated below.

Start pattern, 8 Command, 8 Count, 8 bits Checksum, 8 bits bits bitsThe commands are sent continuously during a rather long time period(e.g. about 30 seconds or more). When a new contract or enlarge step isdesired the Count byte is increased by one to allow the implantedcontrol unit 138 to decode and understand that another step is demandedby the external control unit 136. If any part of the digital packet iserroneous, its content is simply ignored.

Through a line 140, an implanted energizer unit 126 draws energy fromthe high frequency electromagnetic wave signals received by thereceiving antenna 134. The energizer unit 126 stores the energy in apower supply, such as a large capacitor, powers the control unit 138 andpowers the electric motor 128 via a line 142.

The control unit 138 comprises a demodulator and a microprocessor. Thedemodulator demodulates digital signals sent from the external controlunit 136. The microprocessor of the control unit 138 receives thedigital packet, decodes it and, provided that the power supply of theenergizer unit 126 has sufficient energy stored, sends a signal via asignal line 144 to the motor 128 to either contract or enlarge therestriction device depending on the received command code.

Alternatively, the energy stored in the power supply of the energizerunit may only be used for powering a switch, and the energy for poweringthe motor 128 may be obtained from another implanted power source ofrelatively high capacity, for example a battery. In this case the switchis adapted to connect said battery to the control unit 138 in an on modewhen said switch is powered by said power supply and to keep saidbattery disconnected from the control unit in a “standby” mode when saidswitch is unpowered.

With reference to FIG. 14, the remote control schematically describedabove will now be described in accordance with a more detailedembodiment. The external control unit 136 comprises a microprocessor146, a signal generator 148 and a power amplifier 150 connected thereto.The microprocessor 146 is adapted to switch the signal generator 148on/off and to modulate signals generated by the signal generator 148with digital commands that are sent to implanted components of theapparatus. The power amplifier 150 amplifies the signals and sends themto the external signal transmitting antenna 132. The antenna 132 isconnected in parallel with a capacitor 152 to form a resonant circuittuned to the frequency generated by the signal generator 148.

The implanted signal receiving antenna coil 134 forms together with acapacitor 154 a resonant circuit that is tuned to the same frequency asthe transmitting antenna 132. The signal receiving antenna coil 134induces a current from the received high frequency electromagnetic wavesand a rectifying diode 160 rectifies the induced current, which chargesa storage capacitor 158. A coil 156 connected between the antenna coil134 and the diode 160 prevents the capacitor 158 and the diode 160 fromloading the circuit of the signal receiving antenna 134 at higherfrequencies. Thus, the coil 156 makes it possible to charge thecapacitor 158 and to transmit digital information using amplitudemodulation.

A capacitor 162 and a resistor 164 connected in parallel and a diode 166forms a detector used to detect amplitude modulated digital information.A filter circuit is formed by a resistor 158 connected in series with aresistor 170 connected in series with a capacitor 172 connected inseries with the resistor 168 via ground, and a capacitor 174, oneterminal of which is connected between the resistors 168,170 and theother terminal of which is connected between the diode 166 and thecircuit formed by the capacitor 162 and resistor 164. The filter circuitis used to filter out undesired low and high frequencies. The detectedand filtered signals are fed to an implanted microprocessor 176 thatdecodes the digital information and controls the motor 128 via anH-bridge 178 comprising transistors 180,182,184 and 186. The motor 128can be driven in two opposite directions by the H-bridge 178.

The microprocessor 176 also monitors the amount of stored energy in thestorage capacitor 158. Before sending signals to activate the motor 123,the microprocessor 176 checks whether the energy stored in the storagecapacitor 158 is enough. If the stored energy is not enough to performthe requested operation, the microprocessor 176 waits for the receivedsignals to charge the storage capacitor 158 before activating the motor128.

In the practice of the present invention the details of the elongatedrestriction device 4 (such as a gastric band) and theadjustment/operation device (which may have electric, hydraulic, ormechanical, etc. actuation) 6, may be as described in copendingapplication Ser. No. 09/133,319, filed Aug. 13, 1998 (Atty Ref:2333-12), Ser. No. 09/133,320, filed Aug. 13, 1998 (Atty Ref: 2333-11)and Ser. No. 09/133,322, filed Aug. 13, 1998 Ref: 2333-13), thedisclosures of which are incorporated by reference herein.

The invention also comprises or consists of the foregoing structures andmethod steps, and is to be interpreted as broadly as allowed by theprior art

What is claimed is:
 1. A method for treating a patient suffering fromanal incontinence by implanting an anal incontinence treatmentapparatus, the method comprising the steps of: cutting the skin of thepatient, placing at least two laparascopic trocars in the patient'sbody, inserting at least one dissecting tool through at least one of thetrocars, dissecting an area of the fecal passageway using said at leastone dissecting tool, placing, in the patient, an operable restrictiondevice, adapted to be energized by a source of energy, placing theoperable restriction device in the dissected area, and forming arestricted fecal passageway, wherein the operable restriction device isadapted to be energized to change the fecal passageway, controlled fromoutside the patient's body.
 2. The method according to claim 1, whereinthe operable restriction device is adapted to be energized to open andclose, respectively, the fecal passageway, the method comprising thesteps of: enlarging the restricted fecal passageway to allow fecalmatter to readily pass therethrough, and restricting the fecalpassageway, energizing the operable restriction device, when performingthe step of enlarging and restricting the fecal passageway.
 3. Themethod according to claim 1, the method comprising the steps of:providing a source of energy external to the patient's body, controllingthe external source of energy from outside the patient's body, releasingwireless energy, and using the released wireless energy in connectionwith the operation of the operable restriction device.
 4. The methodaccording to claim 1, wherein the method of implanting the analincontinence treatment apparatus uses an implantable energy transformingdevice for the method step of: placing in the patient, the energytransforming device adapted to transform wireless energy into an energyform different than the wireless energy used in connection with theoperation of the restriction device.
 5. The method according to claim 4,wherein the method of implanting the anal incontinence treatmentapparatus comprises the method steps of; providing an external source ofenergy, controlling the external source of energy to release wirelessenergy, transforming the wireless energy by the energy transformingdevice into an energy form different than the wireless energy, and usingthe different energy form in connection with the operation of therestriction device.
 6. The method according to claim 1, wherein themethod of implanting the anal incontinence treatment apparatus uses animplantable source of energy for the method step of: placing, in thepatient, the internal source of energy, adapted to supply energy inconnection with the operation of the restriction device.
 7. The methodaccording to claim 4, wherein the method of implanting the analincontinence treatment apparatus uses art implantable source of energyfor the method step of: placing, in the patient, the implantable sourceof energy adapted to store energy from the energy transforming device inthe internal source of energy.
 8. The method according to claim 4,wherein the method of implanting the anal incontinence treatmentapparatus uses an implantable stabilizer for the method step of:placing, in the patient, the implantable stabilizer, adapted to be ableto stabilize the energy transformed by the energy transforming device.9. The method according to claim 1, wherein the operable restrictiondevice comprises; an electrically powered hydraulically operablerestriction device, wherein the anal incontinence treatment apparatuscomprises a reservoir and an operation device, wherein the step ofplacing the operable restriction device in the patient further comprisesthe steps of: placing, in the patient, the electrically poweredhydraulically operable restriction device, placing a reservoir adaptedto contain hydraulic fluid, placing an operation device adapted tooperate the hydraulically operable restriction device to move hydraulicfluid between the reservoir and the hydraulically operable, restrictiondevice and back, to restrict or release the hydraulically operablerestriction device.
 10. The method according to claim 9, furthercomprising: operating, from outside the patient's body, thehydraulically operable restriction device, using the operation deviceand the hydraulic fluid of the reservoir, and moving hydraulic fluidbetween the reservoir and the hydraulically operable restriction deviceand back, to restrict or release the hydraulically operable restrictiondevice.
 11. The method according to claim 1, wherein the operablerestriction device comprises; a motor op-rated operable restrictiondevice, wherein the anal incontinence treatment apparatus comprises anoperation device and a gearbox, wherein the step of placing the operablerestriction device in the patient, further comprising the steps of:implanting, in the patient, the operation device and the gearbox,wherein the operation device comprises a motor, or a motor and a pump.12. The method according to claim 11, wherein the method of implantingthe anal incontinence treatment apparatus further comprises the methodstep of: operating the operable restriction device, using the operationdevice and the gearbox.
 13. The method according to claim 1, wherein themethod of implanting the anal incontinence treatment apparatus uses acontrol device comprising an implantable second control unit for themethod step of: implanting, in the patient, the second control unit ofthe control device adapted to control the operable restriction device inresponse to a signal received from a first control unit operable fromoutside the patient's body.
 14. The method according to claim 13,comprising the method step of: operating the first control unit of thecontrol device from outside the patient's body for providing the signal,controlling, by the implanted second control unit of the control device,the operable restriction device in response to the signal received fromthe first control unit, and operating the operable restriction deviceusing the implanted second control unit of the control device.
 15. Themethod according to claim 1, wherein the method of implanting the analincontinence treatment apparatus uses electrical components comprisingat least one voltage guard for the method step of: placing, in thepatient, implantable electrical components, including placing, in thepatient, at least one implantable voltage level guard adapted to powerthe anal incontinence treatment apparatus.
 16. The method according toclaim 15, comprising the method step of: operating the powered operablerestriction device, using the at least one implantable voltage levelguard.
 17. The method according to claim 1, wherein the method ofimplanting the anal incontinence treatment apparatus uses electricalcomponents comprising at least one stabilizer for the method step of:placing, in the patient, the implantable stabilizer adapted to be usedwhen powering the operable restriction device.
 18. The method accordingto claim 17, comprising the method of: operating the powered operablerestriction device, using the at least one implantable stabilizer. 19.The method according to claim 1, wherein the method of implanting theanal incontinence treatment apparatus uses an implantable internal datacommunicator for the method step of: placing, in the patient, theinternal data communicator adapted to communicate with an external datacommunicator intended to be placed outside the patient's body.
 20. Themethod according to claim 19, comprising the method step of:communicating by the external, communicator with the internal datacommunicator implantable in the patient, and feeding data from theinternal data communicator related to the patient or operablerestriction device back to the external data communicator.
 21. Themethod according to claim 1, wherein the step of implanting the operablerestriction device further comprises at least one of step a) and b); a)implanting, in the patient, a motor adapted to operate the restrictiondevice, or b) implanting in the patient a pump, adapted to operate therestriction device.
 22. The method according to claim 1, wherein themethod of implanting the anal incontinence treatment apparatus uses animplantable receiving coil antenna for the method step of: implanting,in the patient, a receiving coil antenna comprising a resonant circuitcomprising a capacitor and a coil for receiving transmitted wirelessenergy, wherein said resonant circuit is tuned to the same frequency asthe transmitted wireless energy.
 23. A method for treating a patientsuffering from anal incontinence by implanting an anal incontinencetreatment apparatus, the method comprising the steps of: cutting theskin of the patient, inserting at least one dissecting tool, dissectingan area of a fecal passageway using said at least one dissecting tool,placing, in the patient, an operable restriction device adapted to beenergized by a source of energy, placing the operable restriction devicein the dissected area, and forming a restricted fecal passageway,wherein the operable restriction device is adapted to be energized toopen and close, respectively, the fecal passageway, controlled fromoutside the patient's body.
 24. The method according to claim 23, themethod comprising the steps of: enlarging the restricted fecalpassageway to allow fecal matter to readily pass therethrough, andrestricting the fecal passageway, thereby energizing the operablerestriction device to open and close, respectively, the fecalpassageway.
 25. The method according to claim 23, the method comprisingthe steps of: providing a source of energy external to the patient'sbody, controlling the external source of energy from outside thepatient's body, releasing wireless energy and using the releasedwireless energy in connection with the operation of the operablerestriction device.
 26. The method according to claim 23, wherein themethod of implanting the anal incontinence treatment apparatus uses animplantable energy transforming device for the method step of: placing,in the patient, the energy transforming device adapted to transformwireless energy into an energy form different than the wireless energyused in connection with the operation of the restriction device.
 27. Themethod according to claim 26, wherein the method of implanting the analincontinence treatment apparatus comprises the method steps of;providing an external source of energy, controlling the external sourceof energy to release wireless energy, transforming the wireless energyby the energy transforming device into an energy form different than thewireless energy, and using the different energy form in connection withthe operation of the restriction device.
 28. The method according toclaim 23, wherein the method of implanting the anal incontinencetreatment apparatus uses an implantable source of energy for the methodstep of: placing, in the patient, the implantable source of energy,adapted to supply energy in connection with the operation of therestriction device.
 29. The method according to claim 26, wherein themethod of implanting the anal incontinence treatment apparatus uses animplantable source of energy for the method step of: placing, in thepatient, the implantable source of energy adapted to store energy fromthe energy transforming device in the internal source of energy.
 30. Themethod according to claim 26, wherein the method of implanting the analincontinence treatment apparatus uses an implantable stabilizer for themethod step of: placing, in the patient, the implantable stabilizer,adapted to be able to stabilize the energy transformed by the energytransforming device.
 31. The method according to claim 23, wherein theoperable restriction device comprises an electrically poweredhydraulically operable restriction device, wherein the anal incontinencetreatment apparatus comprises a reservoir and an operation device,wherein the step of placing the operable restriction device in thepatient, further comprising the steps of: placing, in the patient, theelectrically powered hydraulically operable restriction device, placinga reservoir adapted to contain hydraulic fluid, placing an operationdevice, adapted to operate the hydraulically operable restriction deviceto move hydraulic fluid between the reservoir and the hydraulicallyoperable restriction device and back, to restrict or release thehydraulically operable restriction device.
 32. The method according toclaim 31, further comprising: operating from outside the patient's bodythe hydraulically operable restriction device, using the operationdevice and the hydraulic fluid of the reservoir, and moving hydraulicfluid between the reservoir and the hydraulically operable restrictiondevice and back, to restrict release the hydraulically operablerestriction device.
 33. The method according to claim 23, wherein theoperable restriction device comprises; a motor operated operablerestriction device, wherein the anal incontinence treatment apparatuscomprises an operation device and a gearbox, wherein the step of placingthe operable restriction device in the patient further comprises thesteps of: implanting, in the patient, an operation device and a gearbox,wherein the operation device comprises a motor, or a motor and a pump.34. The method according to claim 33, wherein the method of implantingthe anal incontinence treatment apparatus further comprises the methodstep of: operating the operable restriction device, using the operationdevice and the gearbox.
 35. The method according to claim 23, whereinthe method of implanting the anal incontinence treatment apparatus usesa control device comprising a second control unit for the method stepof: implanting, in the patient, the second control unit of the controldevice, adapted to control the operable restriction device in responseto a signal received from a first control unit operable from outside thepatient's body.
 36. The method according to claim 35, comprising themethod step of: operating the first control unit of the control devicefrom outside the patient's body for providing the signal, controlling bythe second implantable control unit of the control device the operablerestriction device in response to the signal received from the firstcontrol unit, and operating the operable restriction device, using theusing the implantable second control unit of the control device.
 37. Themethod according to claim 23, wherein the method of implanting an analincontinence treatment apparatus uses electrical components comprisingat least one voltage guard for the method step of: placing, in thepatient, implantable electrical components, including placing, in thepatient, at least one implantable voltage level guard, adapted to powerthe anal incontinence treatment apparatus.
 38. The method according toclaim 37, comprising the method of: operating the powered operablerestriction device, using the at least one implantable voltage levelguard.
 39. The method according to claim 23, wherein the method ofimplanting an anal incontinence treatment apparatus uses electricalcomponents comprising a stabilizer for the method step of: placing, inthe patient, the implantable stabilizer, adapted to be used whenpowering the operable restriction device.
 40. The method according toclaim 39, comprising the method of: operating the powered operablerestriction device, using the at least one implantable stabilizer. 41.The method according to claim 23, wherein the method of implanting ananal incontinence treatment apparatus uses an implantable internal datacommunicator for the method step of: placing, in the patient, theinternal data communicator adapted to communicate with an external datacommunicator intended to be placed outside the patient's body.
 42. Themethod according to claim 41, comprising the method step of:communicating by the external communicator with the internal datacommunicator implantable in the patient, and feeding data from theinternal data communicator related to the patient or operablerestriction device back to the external data communicator.
 43. Themethod according to claim 23, wherein the step of implanting theoperable restriction device further comprises at least one of step a)and b); a) implanting, in the patient, a motor adapted to operate therestriction device, or b) implanting, in the patient, a pump adapted tooperate the restriction device.
 44. The method according to claim 23,wherein the method of implanting an anal incontinence treatmentapparatus uses an implantable receiving coil antenna for the method stepof: implanting in the patient a receiving coil antenna comprising aresonant circuit comprising a capacitor and a coil for receivingtransmitted wireless energy, wherein said resonant circuit is tuned tothe same frequency as the transmitted wireless energy.